一种用于植物源单克隆抗体在疫苗纯化中实际应用的整体方法。

An integral approach towards a practical application for a plant-made monoclonal antibody in vaccine purification.

作者信息

Pujol Merardo, Ramírez Nadia I, Ayala Marta, Gavilondo Jorge V, Valdés Rodolfo, Rodríguez Meilyn, Brito José, Padilla Sigifredo, Gómez Leonardo, Reyes Biunaiky, Peral Rudy, Pérez Marlene, Marcelo José L, Milá Lorely, Sánchez Rafael F, Páez Rolando, Cremata José A, Enríquez Gil, Mendoza Otto, Ortega Mercedes, Borroto Carlos

机构信息

Centre for Genetic Engineering and Biotechnology, A.P. 6162, C.P. 10600, Havana, Cuba.

出版信息

Vaccine. 2005 Mar 7;23(15):1833-7. doi: 10.1016/j.vaccine.2004.11.023.

DOI:10.1016/j.vaccine.2004.11.023

PMID:15734051

Abstract

The use of transgenic plants for the production of pharmaceutical compounds has received increasing attention in the last few years. However, many technological and regulatory issues regarding the practical exploitation of this alternative system of production remain to be solved; a situation that explains the lack of commercial products derived from such a system. This paper reports the expression in transgenic plants and cells of a single-chain antibody variable-region fragment (scFv) and a mouse monoclonal antibody to the hepatitis B virus surface antigen (HBsAg). The large-scale purification of the scFv from plants and its use for immunopurification of HBsAg are also described, together with elements concerning regulatory issues and technologies for compliance with good manufacturing and agricultural practices.

摘要

在过去几年中，利用转基因植物生产药物化合物受到了越来越多的关注。然而，关于这种替代性生产系统的实际应用，仍有许多技术和监管问题有待解决；这种情况解释了为何缺乏源自该系统的商业产品。本文报道了单链抗体可变区片段（scFv）和针对乙型肝炎病毒表面抗原（HBsAg）的小鼠单克隆抗体在转基因植物和细胞中的表达。还描述了从植物中大规模纯化scFv及其用于免疫纯化HBsAg的情况，以及有关监管问题和符合良好生产及农业规范的技术要素。